Hemorrhoids: Options of Traditional Hemorrhoidectomy

NCT06132152 | Unknown

• 1 other identifier: 59954654
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. Randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. All information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.

Conditions

Hemorrhoids; Open Hemorrhoidectomy

Keywords

symptomatic hemorrhoids; open hemorrhoidectomy; postoperative pain; electrosurgery

Outcome Measures

Primary Outcomes (1)

• Pain at rest and during defecation

  The pain was assessed using a visual analogue scale (VAS uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end)

  during 10 days after surgery

Secondary Outcomes (6)

• Rate of prescribing opioid analgesics

  3 days after surgery

• Other medications use

  10 days after surgery

• Readmission rate

  30 days after surgery

• The life quality rate

  7 and 30 days

• Complication rate

  within 30 days after surgery

Study Arms (2)

Open hemorrhoidectomy with 'cold' scalpel

ACTIVE COMPARATOR

Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose.

Procedure: Open hemorrhoidectomy with 'cold' scalpel

Open hemorrhoidectomy with electrosurgical scalpel

ACTIVE COMPARATOR

Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding.

Procedure: Open hemorrhoidectomy with electrosurgical scalpel

Interventions

Open hemorrhoidectomy with 'cold' scalpel PROCEDURE

Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. 'Cold' scalpel will be used for cutting the perianal skin and anal mucose. To stop and prevent bleeding the monopolar coagulation may be used but on low energy level and with no touching the skin and mucose.

Open hemorrhoidectomy with 'cold' scalpel

Open hemorrhoidectomy with electrosurgical scalpel PROCEDURE

Open hemorrhoidectomy will be performed in traditional way, including radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Electrosurgical scalpel will be used during all steps including cutting the perianal skin and anal mucose and to stop and prevent bleeding.

Open hemorrhoidectomy with electrosurgical scalpel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• Diagnosed symptomatic hemorrhoidal disease
• Planned surgery - open hemorrhoidectomy
• Absence of other anarectal diseases
• I, II class of anesthetic risk according to ASA classification
• Voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial.

You may not qualify if:

• Chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases.
• Patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease.
• Patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention).
• Pregnant women
• Complicated course of the postoperative period due to exacerbation of concomitant diseases

Sponsors & Collaborators

• Center of Endourology "Endocenter": lead

Study Sites (1)

Surgical department of the Medical Research and Educational Center of Lomonosov Moscow State University

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative; Hyperthermia

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Tatiana Garmanova, PhD

CONTACT

+79773429249; tatianagarmanova@gmail.com

Ekaterina Kazachenko, MD

CONTACT

+79269721922; ekaterina.k.97@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Before the operation, all patients are scheduled to perform an open hemorrhoidectomy, which includes radial skin-mucosal excision of enlarged hemorrhoids with ligation of the vascular pedicle. Patients are not informed about which instrument will be used. All collected information will be stored in electronic databases, where patient names and group numbers are anonymized and encrypted. Thus, during the statistical calculation, a person will not know about the name of the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In case of meeting inclusion criteria of patient the selection of the group will be determined by randomization, so both groups will be recruited simultaneously

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 15, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)